BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER TM REVERSE SHOULDER

    MDR report key: 4223294 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01470
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER NO INFORMATION HAS BEEN RECEIVED TO DATE. THE PROVIDED INFORMATION INDICATES THE FRACTURE WAS DUE TO A FALL AND NOT RELATED TO THE DEVICES; HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED, THE PATIENT WAS REVISED DUE TO A FALL, WHICH FRACTURED THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691303 UNKNOWN ZIMMER TM REVERSE SHOULDER SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention